Toxicology Data Management System Page: 1 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 055021503 03/04/97 730 50(1) 38 (707) 53.4 ACRYLONITRILE | |BATTELLE COLUMBUS 055634804 06/19/96 727 100(1) 91 (707) 49.6 CITRAL | |BATTELLE COLUMBUS 058803106 03/19/97 729 50(1) 40 (703) 53.9 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058812207 07/01/97 730 50(1) 39 (702) 52.5 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805006 10/16/95 729 49(1) 35 (704) 50.6 METHACRYLONITRILE | |BATTELLE COLUMBUS 058812004 01/04/96 733 50(1) 40 (705) 46.9 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 058800706 08/02/95 727 50(1) 39 (708) 51.4 SODIUM NITRITE | |BATTELLE COLUMBUS 055611104 09/24/97 728 100(1) 91 (705) 46.5 TRANS-CINNAMALDEHYDE | |BATTELLE COLUMBUS 050510914 09/24/98 726 50(1) 37 (710) 53.4 TRIETHANOLAMINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE COLUMBUS 055021503 03/04/97 729 50(5) 39 (709) 62.7 ACRYLONITRILE | |BATTELLE COLUMBUS 055634804 06/19/96 733 99(5) 81 (695) 48.0 CITRAL | |BATTELLE COLUMBUS 058803106 03/19/97 728 50(5) 37 (699) 61.4 DIPROPYLENE GLYCOL | |BATTELLE COLUMBUS 058812207 07/01/97 729 50(5) 37 (692) 62.9 ELMIRON (SODIUM PENTOSANPOLYSULFATE) | |BATTELLE COLUMBUS 058805006 10/16/95 731 50(5) 35 (700) 58.1 METHACRYLONITRILE | |BATTELLE COLUMBUS 058812004 01/04/96 734 50(5) 42 (717) 46.5 P,P'-DICHLORODIPHENYL SULFONE | |BATTELLE COLUMBUS 058800706 08/02/95 728 50(5) 40 (702) 58.8 SODIUM NITRITE | |BATTELLE COLUMBUS 055611104 09/24/97 733 100(5) 84 (711) 46.0 TRANS-CINNAMALDEHYDE | |BATTELLE COLUMBUS 050510914 09/24/98 729 50(1) 35 (692) 62.7 TRIETHANOLAMINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 2 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302606 08/28/97 733 50( ) 40 (701) 54.1 DECALIN | |BATTELLE NORTHWEST 058812404 01/25/96 733 50( ) 37 (711) 51.6 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 059000406 09/29/97 729 50( ) 35 (703) 54.3 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600106 12/21/98 729 50( ) 34 (690) 53.0 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142708 01/13/97 729 50( ) 39 (710) 55.4 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |BATTELLE NORTHWEST 059302606 08/28/97 735 49( ) 37 (708) 61.5 DECALIN | |BATTELLE NORTHWEST 058812404 01/25/96 735 50( ) 42 (713) 54.8 INDIUM PHOSPHIDE | |BATTELLE NORTHWEST 059000406 09/29/97 731 50( ) 39 (718) 59.8 PROPYLENE GLYCOL MONO-T-BUTYL ETHER | |BATTELLE NORTHWEST 059600106 12/21/98 731 50( ) 36 (702) 54.6 STODDARD SOLVENT (TYPE IIC) | |BATTELLE NORTHWEST 056142708 01/13/97 731 50( ) 38 (692) 58.7 VANADIUM PENTOXIDE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 3 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |IITRI 058902906 10/05/94 734 100(1) 76 (711) 53.4 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |IITRI 058902906 10/05/94 735 100(5) 70 (702) 59.7 MAGNETIC FIELDS (EMF) | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 4 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Study Summary ________________________________________________________________________________________________________________________________ | | | Length Number Number Maximum | | Study of of Animals Surviving Mean | |Laboratory Study Start Study Total and and (Mean Weekly Body | |Name Number Date in Days (#/Cage) Life Span) Weight Chemical | |________________________________________________________________________________________________________________________________| | | | MALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302307 07/25/97 729 50(1) 44 (721) 57.3 2,4-HEXADIENAL | |SOUTHERN RESEARCH 059201206 07/29/98 729 50(1) 43 (706) 46.8 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520309 02/20/96 729 60(1) 52 (712) 48.0 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520508 11/14/95 729 50(1) 46 (722) 47.4 P-NITROTOLUENE | |SOUTHERN RESEARCH 050516106 03/20/96 729 50(1) 39 (696) 51.4 RIDDELLIINE | |________________________________________________________________________________________________________________________________| | | | FEMALE | |________________________________________________________________________________________________________________________________| | | |SOUTHERN RESEARCH 059302307 07/25/97 732 50(5) 42 (717) 64.2 2,4-HEXADIENAL | |SOUTHERN RESEARCH 059201206 07/29/98 732 50(5) 46 (720) 38.8 2-METHYLIMIDAZOLE | |SOUTHERN RESEARCH 050520309 02/20/96 731 60(5) 52 (708) 46.6 O-NITROTOLUENE | |SOUTHERN RESEARCH 050520508 11/14/95 732 50(5) 46 (727) 41.4 P-NITROTOLUENE | |SOUTHERN RESEARCH 050516106 03/20/96 735 50(5) 34 (674) 59.5 RIDDELLIINE | |________________________________________________________________________________________________________________________________| Toxicology Data Management System Page: 5 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 34/50 (68%) 40/100(40%) 27/50 (54%) 29/50 (58%) 28/99 (28%) 22/50 (44%) | | 29/50 (58%) 29/49 (59%) 16/50 (32%) 17/50 (34%) 24/50 (48%) 15/50 (30%) | | 28/50 (56%) 37/100(37%) 30/50 (60%) 13/50 (26%) 32/100(32%) 24/50 (48%) | | Overall Incidence Total 270/549 (49.18%)Mean 51.58% SD 12.22% Total 204/549 (37.16%) Mean 38.7% SD 11.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 29/50 (58%) 32/100(32%) 19/50 (38%) 24/50 (48%) 24/99 (24%) 18/50 (36%) | | 24/50 (48%) 24/49 (49%) 21/50 (42%) 17/50 (34%) 20/50 (40%) 12/50 (24%) | | 27/50 (54%) 28/100(28%) 28/50 (56%) 12/50 (24%) 46/100(46%) 27/50 (54%) | | Overall Incidence Total 232/549 (42.26%)Mean 45% SD 10.68% Total 200/549 (36.43%) Mean 36.69% SD 11.24% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 45/50 (90%) 55/100(55%) 39/50 (78%) 39/50 (78%) 45/99 (45%) 32/50 (64%) | | 38/50 (76%) 40/49 (82%) 32/50 (64%) 29/50 (58%) 34/50 (68%) 23/50 (46%) | | 40/50 (80%) 57/100(57%) 45/50 (90%) 21/50 (42%) 62/100(62%) 38/50 (76%) | | Overall Incidence Total 391/549 (71.22%)Mean 74.63% SD 13.1% Total 323/549 (58.83%) Mean 59.94% SD 13.23% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 2/50 (4%) 2/100(2%) 2/50 (4%) 0/50 (0%) 1/99 (1%) 2/50 (4%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 3/100(3%) 1/50 (2%) 0/50 (0%) 4/100(4%) 1/50 (2%) | | Overall Incidence Total 10/549 (1.82%) Mean 1.67% SD 1.73% Total 10/549 (1.82%) Mean 1.67% SD 1.87% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 3/50 (6%) 3/100(3%) 0/50 (0%) 4/50 (8%) 0/99 (0%) 3/50 (6%) | | 6/50 (12%) 3/49 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | | 7/50 (14%) 2/100(2%) 3/50 (6%) 1/50 (2%) 1/100(1%) 3/50 (6%) | | Overall Incidence Total 30/549 (5.46%) Mean 6.12% SD 4.48% Total 15/549 (2.73%) Mean 3.22% SD 2.91% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 5/50 (10%) 5/100(5%) 2/50 (4%) 4/50 (8%) 1/99 (1%) 5/50 (10%) | | 6/50 (12%) 3/49 (6%) 3/50 (6%) 1/50 (2%) 4/50 (8%) 0/50 (0%) | | 7/50 (14%) 5/100(5%) 4/50 (8%) 1/50 (2%) 5/100(5%) 4/50 (8%) | | Overall Incidence Total 40/549 (7.29%) Mean 7.79% SD 3.48% Total 25/549 (4.55%) Mean 4.89% SD 3.72% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 4/50 (8%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 7/549 (1.28%) Mean 1.33% SD 2.65% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/50 (6%) 4/100(4%) 1/50 (2%) 4/50 (8%) 7/99 (7%) 5/50 (10%) | | Lymphocytic, Mixed, NOS, or 3/50 (6%) 2/49 (4%) 3/50 (6%) 7/50 (14%) 9/50 (18%) 6/50 (12%) | | Undifferentiated Cell Type 1/50 (2%) 8/100(8%) 0/50 (0%) 7/50 (14%) 23/100(23%) 8/50 (16%) | | Overall Incidence Total 25/549 (4.55%) Mean 4.23% SD 2.54% Total 76/549 (13.84%) Mean 13.56% SD 5.04% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 6 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | NOS 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 1/50 (2%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 4/549 (0.73%) Mean 0.78% SD 0.97% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 1/50 (2%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 4/549 (0.73%) Mean 0.78% SD 0.97% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 3/50 (6%) 2/100(2%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 2/50 (4%) 5/49 (10%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 2/99 (2%) 3/50 (6%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 17/547 (3.11%) Mean 3.36% SD 3.51% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/547 (0%) Mean 0% SD 0% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/547 (0%) Mean 0% SD 0% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 7 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/99 (0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 1/49 (2%) | | Overall Incidence Total 1/546 (0.18%) Mean 0.22% SD 0.67% Total 1/545 (0.18%) Mean 0.23% SD 0.68% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/49 (0%) | | Overall Incidence Total 0/546 (0%) Mean 0% SD 0% Total 3/545 (0.55%) Mean 0.45% SD 0.73% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | Complex, Malignant, NOS 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 0/99 (0%) 1/50 (2%) 0/50 (0%) 1/99 (1%) 1/49 (2%) | | Overall Incidence Total 1/546 (0.18%) Mean 0.22% SD 0.67% Total 4/545 (0.73%) Mean 0.67% SD 0.87% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 6/549 (1.09%) Mean 1.33% SD 2% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.33% SD 0.71% Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 8 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 1/549 (0.18%) Mean 0.11% SD 0.34% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 3/549 (0.55%) Mean 0.56% SD 0.88% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 3/549 (0.55%) Mean 0.56% SD 0.88% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/98 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/547 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/98 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/547 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/547 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 9 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | Astrocytoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/547 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.22% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.22% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Coagulating Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor, Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 10 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Sarcoma 0/50 (0%) 0/100(0%) 0/48 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/40 (0%) 0/46 (0%) 0/49 (0%) 0/39 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/48 (0%) 0/48 (0%) 0/100(0%) 0/48 (0%) | | Overall Incidence Total 0/531 (0%) Mean 0% SD 0% Total 0/533 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 5/50 (10%) 4/100(4%) 2/50 (4%) 10/50 (20%) 3/99 (3%) 1/50 (2%) | | 6/50 (12%) 3/49 (6%) 5/50 (10%) 4/50 (8%) 2/50 (4%) 3/50 (6%) | | 4/50 (8%) 8/100(8%) 7/50 (14%) 0/50 (0%) 2/100(2%) 5/50 (10%) | | Overall Incidence Total 44/549 (8.01%) Mean 8.46% SD 3.42% Total 30/549 (5.46%) Mean 6.11% SD 6.09% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 1/50 (2%) 0/100(0%) 1/50 (2%) 1/50 (2%) 1/99 (1%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 2/50 (4%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.44% SD 0.88% Total 7/549 (1.28%) Mean 1.33% SD 1.66% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 6/50 (12%) 4/100(4%) 3/50 (6%) 11/50 (22%) 4/99 (4%) 1/50 (2%) | | 6/50 (12%) 3/49 (6%) 5/50 (10%) 4/50 (8%) 4/50 (8%) 3/50 (6%) | | 4/50 (8%) 8/100(8%) 7/50 (14%) 0/50 (0%) 3/100(3%) 7/50 (14%) | | Overall Incidence Total 46/549 (8.38%) Mean 8.9% SD 3.32% Total 37/549 (6.74%) Mean 7.45% SD 6.84% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | Overall Incidence Total 0/548 (0%) Mean 0% SD 0% Total 1/548 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 1/548 (0.18%) Mean 0.22% SD 0.67% Total 0/548 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 11 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 3/549 (0.55%) Mean 0.67% SD 2% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Polyp Adenomatous 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.45% SD 1.36% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 12 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 1/50 (2%) 2/100(2%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 7/549 (1.28%) Mean 1.22% SD 1.39% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 2/50 (4%) 3/100(3%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 4/50 (8%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 1/100(1%) 3/50 (6%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 20/549 (3.64%) Mean 4% SD 3.35% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.45% SD 1.36% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 2/50 (4%) 3/100(3%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 4/50 (8%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 1/100(1%) 3/50 (6%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 20/549 (3.64%) Mean 4% SD 3.35% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 13 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 2/50 (4%) 3/100(3%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 4/50 (8%) 3/49 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 5/50 (10%) 1/100(1%) 3/50 (6%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 22/549 (4.01%) Mean 4.46% SD 3.33% Total 3/549 (0.55%) Mean 0.56% SD 0.88% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 1/50 (2%) 2/100(2%) 2/50 (4%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 8/549 (1.46%) Mean 1.44% SD 1.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/50 (4%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 2/50 (4%) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) | | 3/50 (6%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 8/549 (1.46%) Mean 1.68% SD 2.36% Total 2/545 (0.37%) Mean 0.44% SD 1.33% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/545 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/50 (4%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 2/50 (4%) | | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 1/50 (2%) | | 3/50 (6%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 8/549 (1.46%) Mean 1.68% SD 2.36% Total 3/545 (0.55%) Mean 0.67% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 3/549 (0.55%) Mean 0.67% SD 1% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 14 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 3/549 (0.55%) Mean 0.67% SD 1% Total 0/547 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/547 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 2/548 (0.36%) Mean 0.44% SD 0.88% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 2/50 (4%) 2/100(2%) 0/50 (0%) 2/50 (4%) 0/99 (0%) 2/50 (4%) | | 2/50 (4%) 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 12/549 (2.19%) Mean 2.45% SD 1.67% Total 5/548 (0.91%) Mean 1.11% SD 1.76% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 5/50 (10%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 8/549 (1.46%) Mean 1.78% SD 3.23% Total 0/548 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 23/50 (46%) 20/100(20%) 17/50 (34%) 14/50 (28%) 8/99 (8%) 11/50 (22%) | | 19/50 (38%) 17/49 (35%) 6/50 (12%) 7/50 (14%) 9/50 (18%) 4/50 (8%) | | 19/50 (38%) 14/100(14%) 19/50 (38%) 9/50 (18%) 7/99 (7%) 9/50 (18%) | | Overall Incidence Total 154/549 (28.05%)Mean 30.52% SD 12.06% Total 78/548 (14.23%) Mean 15.68% SD 7.08% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 14/50 (28%) 13/100(13%) 14/50 (28%) 7/50 (14%) 4/99 (4%) 7/50 (14%) | | 11/50 (22%) 13/49 (27%) 9/50 (18%) 3/50 (6%) 2/50 (4%) 3/50 (6%) | | 9/50 (18%) 13/100(13%) 17/50 (34%) 2/50 (4%) 3/99 (3%) 6/50 (12%) | | Overall Incidence Total 113/549 (20.58%)Mean 22.28% SD 7.33% Total 37/548 (6.75%) Mean 7.45% SD 4.55% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 15 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 14/50 (28%) 13/100(13%) 14/50 (28%) 7/50 (14%) 4/99 (4%) 7/50 (14%) | | Hepatoblastoma 12/50 (24%) 14/49 (29%) 9/50 (18%) 3/50 (6%) 2/50 (4%) 3/50 (6%) | | 12/50 (24%) 13/100(13%) 18/50 (36%) 2/50 (4%) 3/99 (3%) 6/50 (12%) | | Overall Incidence Total 119/549 (21.68%)Mean 23.62% SD 7.69% Total 37/548 (6.75%) Mean 7.45% SD 4.55% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 32/50 (64%) 28/100(28%) 29/50 (58%) 20/50 (40%) 12/99 (12%) 17/50 (34%) | | Hepatocellular Adenoma 23/50 (46%) 24/49 (49%) 15/50 (30%) 10/50 (20%) 10/50 (20%) 6/50 (12%) | | 24/50 (48%) 26/100(26%) 33/50 (66%) 10/50 (20%) 9/99 (9%) 12/50 (24%) | | Overall Incidence Total 234/549 (42.62%)Mean 46.11% SD 15.25% Total 106/548 (19.34%) Mean 21.25% SD 10.27% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 32/50 (64%) 28/100(28%) 29/50 (58%) 20/50 (40%) 12/99 (12%) 17/50 (34%) | | Hepatocellular Adenoma, or 24/50 (48%) 24/49 (49%) 15/50 (30%) 10/50 (20%) 10/50 (20%) 6/50 (12%) | | Hepatoblastoma 26/50 (52%) 26/100(26%) 33/50 (66%) 10/50 (20%) 9/99 (9%) 12/50 (24%) | | Overall Incidence Total 237/549 (43.17%)Mean 46.78% SD 15.38% Total 106/548 (19.34%) Mean 21.25% SD 10.27% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.23% SD 0.68% Total 1/548 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/548 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 10/50 (20%) 12/100(12%) 3/50 (6%) 4/50 (8%) 5/99 (5%) 2/50 (4%) | | 10/50 (20%) 2/49 (4%) 6/50 (12%) 2/50 (4%) 6/50 (12%) 0/50 (0%) | | 10/50 (20%) 9/100(9%) 6/50 (12%) 1/50 (2%) 3/100(3%) 3/50 (6%) | | Overall Incidence Total 68/549 (12.39%) Mean 12.79% SD 6.06% Total 26/549 (4.74%) Mean 4.89% SD 3.52% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 4/50 (8%) 9/100(9%) 3/50 (6%) 2/50 (4%) 6/99 (6%) 2/50 (4%) | | 5/50 (10%) 4/49 (8%) 7/50 (14%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | 4/50 (8%) 7/100(7%) 7/50 (14%) 0/50 (0%) 2/100(2%) 2/50 (4%) | | Overall Incidence Total 50/549 (9.11%) Mean 9.35% SD 2.86% Total 16/549 (2.91%) Mean 2.67% SD 2.01% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 16 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 14/50 (28%) 20/100(20%) 6/50 (12%) 6/50 (12%) 11/99 (11%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma 14/50 (28%) 6/49 (12%) 13/50 (26%) 3/50 (6%) 6/50 (12%) 0/50 (0%) | | 13/50 (26%) 14/100(14%) 12/50 (24%) 1/50 (2%) 5/100(5%) 5/50 (10%) | | Overall Incidence Total 112/549 (20.4%) Mean 21.14% SD 6.75% Total 40/549 (7.29%) Mean 7.12% SD 4.41% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Bronchial: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Mast Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 2/50 (4%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.44% SD 1.33% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 17 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 2/50 (4%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.44% SD 1.33% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 2/50 (4%) | | or Adenoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.44% SD 1.33% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 18 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/96 (0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Overall Incidence Total 0/545 (0%) Mean 0% SD 0% Total 0/548 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 1/50 (2%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 3/549 (0.55%) Mean 0.56% SD 0.88% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 19 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 8/50 (16%) 3/99 (3%) 0/50 (0%) | | 1/47 (2%) 2/50 (4%) 2/50 (4%) | | 0/47 (0%) 2/100(2%) 1/50 (2%) | | Overall Incidence Total 19/543 (3.5%) Mean 3.68% SD 4.84% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/50 (0%) 1/99 (1%) 1/50 (2%) | | 0/47 (0%) 0/50 (0%) 1/50 (2%) | | 0/47 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 4/543 (0.74%) Mean 0.67% SD 0.87% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/50 (0%) 1/99 (1%) 1/50 (2%) | | Malignant, NOS 0/47 (0%) 0/50 (0%) 1/50 (2%) | | 0/47 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 4/543 (0.74%) Mean 0.67% SD 0.87% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/47 (0%) 2/50 (4%) 0/50 (0%) | | 0/47 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 3/543 (0.55%) Mean 0.56% SD 1.33% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 1/543 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 2/100(2%) 1/50 (2%) | | Overall Incidence Total 4/543 (0.74%) Mean 0.56% SD 0.88% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 20 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/47 (0%) 1/50 (2%) 0/50 (0%) | | 0/47 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/543 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/47 (0%) 0/50 (0%) 0/50 (0%) | | 0/47 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 1/543 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/548 (0.18%) Mean 0.11% SD 0.33% Total 0/545 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) 0/50 (0%) 0/50 (0%) | | 0/49 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/548 (0%) Mean 0% SD 0% Total 0/545 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/98 (0%) 0/49 (0%) 2/48 (4%) 8/97 (8%) 1/49 (2%) | | Adenoma 0/47 (0%) 0/48 (0%) 0/49 (0%) 2/48 (4%) 2/49 (4%) 3/48 (6%) | | 0/49 (0%) 0/98 (0%) 0/50 (0%) 1/48 (2%) 11/97 (11%) 8/50 (16%) | | Overall Incidence Total 0/537 (0%) Mean 0% SD 0% Total 38/534 (7.12%) Mean 6.49% SD 4.65% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/98 (0%) 0/49 (0%) 0/48 (0%) 0/97 (0%) 0/49 (0%) | | Carcinoma 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) | | 0/49 (0%) 0/98 (0%) 0/50 (0%) 0/48 (0%) 0/97 (0%) 0/50 (0%) | | Overall Incidence Total 0/537 (0%) Mean 0% SD 0% Total 0/534 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/49 (0%) 0/98 (0%) 0/49 (0%) 2/48 (4%) 8/97 (8%) 1/49 (2%) | | Carcinoma or Adenoma 0/47 (0%) 0/48 (0%) 0/49 (0%) 2/48 (4%) 2/49 (4%) 3/48 (6%) | | 0/49 (0%) 0/98 (0%) 0/50 (0%) 1/48 (2%) 11/97 (11%) 8/50 (16%) | | Overall Incidence Total 0/537 (0%) Mean 0% SD 0% Total 38/534 (7.12%) Mean 6.49% SD 4.65% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 1/49 (2%) 0/98 (0%) 1/49 (2%) 0/48 (0%) 2/97 (2%) 0/49 (0%) | | 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) 2/49 (4%) 1/48 (2%) | | 0/49 (0%) 1/98 (1%) 1/50 (2%) 0/48 (0%) 0/97 (0%) 0/50 (0%) | | Overall Incidence Total 4/537 (0.74%) Mean 0.79% SD 0.99% Total 5/534 (0.94%) Mean 0.91% SD 1.49% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 21 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 1/49 (2%) 0/98 (0%) 1/49 (2%) 0/48 (0%) 2/97 (2%) 0/49 (0%) | | 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) 2/49 (4%) 1/48 (2%) | | 0/49 (0%) 1/98 (1%) 1/50 (2%) 0/48 (0%) 0/97 (0%) 0/50 (0%) | | Overall Incidence Total 4/537 (0.74%) Mean 0.79% SD 0.99% Total 5/534 (0.94%) Mean 0.91% SD 1.49% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.23% SD 0.68% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) 0/98 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/540 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/98 (0%) 0/49 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/49 (0%) 0/98 (0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/540 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 1/50 (2%) 0/100(0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 22 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 1/50 (2%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 1/50 (2%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 2/50 (4%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 3/549 (0.55%) Mean 0.56% SD 1.33% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 23 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Tumor Benign, or 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 2/549 (0.36%) Mean 0.34% SD 0.72% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/100(2%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 3/549 (0.55%) Mean 0.33% SD 0.71% Total 2/549 (0.36%) Mean 0.22% SD 0.44% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 1/50 (2%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.44% SD 0.88% Total 3/549 (0.55%) Mean 0.67% SD 1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.23% SD 0.68% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 24 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.23% SD 0.68% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 1/50 (2%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Carcinoma | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 25 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Keratoacanthoma 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.34% SD 0.72% Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.34% SD 0.72% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/100(1%) 0/50 (0%) 3/50 (6%) 2/99 (2%) 3/50 (6%) | | Myxoma, Myxosarcoma, or Fibrous 0/50 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | | Histiocytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 4/100(4%) 1/50 (2%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 20/549 (3.64%) Mean 3.78% SD 1.85% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 1/100(1%) 0/50 (0%) 2/50 (4%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 4/100(4%) 1/50 (2%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 9/549 (1.64%) Mean 1.56% SD 1.94% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/100(1%) 0/50 (0%) 3/50 (6%) 2/99 (2%) 3/50 (6%) | | Myxosarcoma, or Fibrous 0/50 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | | Histiocytoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 4/100(4%) 1/50 (2%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% Total 20/549 (3.64%) Mean 3.78% SD 1.85% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 4/549 (0.73%) Mean 0.67% SD 1.41% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 26 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | or NOS) 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 4/549 (0.73%) Mean 0.67% SD 1.41% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 2/99 (2%) 3/50 (6%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 10/549 (1.82%) Mean 2% SD 2.45% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 2/100(2%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 4/549 (0.73%) Mean 0.67% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 1/49 (2%) 0/49 (0%) 0/97 (0%) 0/50 (0%) | | Overall Incidence Total 1/547 (0.18%) Mean 0.23% SD 0.68% Total 0/541 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 1/50 (2%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 1/50 (2%) | | 0/49 (0%) 1/49 (2%) 1/50 (2%) 0/47 (0%) 1/50 (2%) 0/49 (0%) | | 3/50 (6%) 1/100(1%) 2/49 (4%) 0/49 (0%) 0/97 (0%) 1/50 (2%) | | Overall Incidence Total 9/547 (1.65%) Mean 1.9% SD 2.04% Total 3/541 (0.55%) Mean 0.67% SD 1% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/50 (0%) 1/100(1%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/49 (0%) 0/49 (0%) 0/97 (0%) 0/50 (0%) | | Overall Incidence Total 1/547 (0.18%) Mean 0.11% SD 0.33% Total 0/541 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/100(0%) 0/49 (0%) 0/49 (0%) 0/97 (0%) 0/50 (0%) | | Overall Incidence Total 0/547 (0%) Mean 0% SD 0% Total 0/541 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 27 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 3/50 (6%) 0/100(0%) 1/50 (2%) 3/50 (6%) 1/99 (1%) 2/50 (4%) | | Papilloma Squamous 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/100(0%) 1/50 (2%) 1/50 (2%) 1/100(1%) 2/50 (4%) | | Overall Incidence Total 7/549 (1.28%) Mean 1.56% SD 1.94% Total 10/549 (1.82%) Mean 2% SD 2.18% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 3/50 (6%) 0/100(0%) 0/50 (0%) 3/50 (6%) 1/99 (1%) 2/50 (4%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/100(0%) 1/50 (2%) 1/50 (2%) 1/100(1%) 2/50 (4%) | | Overall Incidence Total 6/549 (1.09%) Mean 1.34% SD 2% Total 10/549 (1.82%) Mean 2% SD 2.18% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 1/100(1%) 3/50 (6%) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 6/549 (1.09%) Mean 1.11% SD 1.96% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 1/100(1%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) | | 1/50 (2%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 28 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Seratoli Tumor: Benign, 0/50 (0%) 0/100(0%) 0/50 (0%) | | Malignant, NOS 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Sertoli Cell Tumor Malignant 0/50 (0%) 0/100(0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/47 (0%) 0/99 (0%) 0/46 (0%) 0/50 (0%) 0/95 (0%) 1/49 (2%) | | 0/40 (0%) 0/40 (0%) 0/45 (0%) 0/43 (0%) 0/47 (0%) 0/49 (0%) | | 0/37 (0%) 0/87 (0%) 0/48 (0%) 0/46 (0%) 0/93 (0%) 0/49 (0%) | | Overall Incidence Total 0/489 (0%) Mean 0% SD 0% Total 1/521 (0.19%) Mean 0.23% SD 0.68% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/47 (0%) 0/99 (0%) 0/46 (0%) 0/50 (0%) 0/95 (0%) 0/49 (0%) | | 0/40 (0%) 0/40 (0%) 0/45 (0%) 0/43 (0%) 0/47 (0%) 0/49 (0%) | | 0/37 (0%) 0/87 (0%) 0/48 (0%) 1/46 (2%) 0/93 (0%) 0/49 (0%) | | Overall Incidence Total 0/489 (0%) Mean 0% SD 0% Total 1/521 (0.19%) Mean 0.24% SD 0.72% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/47 (0%) 0/99 (0%) 0/46 (0%) 0/50 (0%) 0/95 (0%) 0/49 (0%) | | 0/40 (0%) 0/40 (0%) 0/45 (0%) 0/43 (0%) 0/47 (0%) 0/49 (0%) | | 0/37 (0%) 0/87 (0%) 0/48 (0%) 1/46 (2%) 0/93 (0%) 0/49 (0%) | | Overall Incidence Total 0/489 (0%) Mean 0% SD 0% Total 1/521 (0.19%) Mean 0.24% SD 0.72% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/49 (0%) 0/98 (0%) 0/50 (0%) | | Overall Incidence Total 0/546 (0%) Mean 0% SD 0% Total 0/538 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/49 (0%) | | 0/48 (0%) 1/49 (2%) 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/49 (0%) 0/98 (0%) 0/50 (0%) | | Overall Incidence Total 1/546 (0.18%) Mean 0.23% SD 0.68% Total 0/538 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/49 (0%) | | 0/48 (0%) 1/49 (2%) 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/49 (0%) 0/98 (0%) 0/50 (0%) | | Overall Incidence Total 1/546 (0.18%) Mean 0.23% SD 0.68% Total 0/538 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 29 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 2/50 (4%) 0/97 (0%) 0/49 (0%) | | 0/48 (0%) 0/49 (0%) 1/50 (2%) 0/46 (0%) 0/49 (0%) 2/50 (4%) | | 0/50 (0%) 1/99 (1%) 1/50 (2%) 0/49 (0%) 1/98 (1%) 0/50 (0%) | | Overall Incidence Total 4/546 (0.73%) Mean 0.67% SD 0.87% Total 5/538 (0.93%) Mean 1% SD 1.73% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/97 (0%) 0/49 (0%) | | 0/48 (0%) 1/49 (2%) 0/50 (0%) 0/46 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/99 (0%) 0/50 (0%) 0/49 (0%) 0/98 (0%) 1/50 (2%) | | Overall Incidence Total 1/546 (0.18%) Mean 0.23% SD 0.68% Total 1/538 (0.19%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/50 (0%) 1/100(1%) 0/50 (0%) 2/50 (4%) 0/97 (0%) 0/49 (0%) | | 0/48 (0%) 1/49 (2%) 1/50 (2%) 0/46 (0%) 0/49 (0%) 2/50 (4%) | | 0/50 (0%) 1/99 (1%) 1/50 (2%) 0/49 (0%) 1/98 (1%) 1/50 (2%) | | Overall Incidence Total 5/546 (0.92%) Mean 0.89% SD 0.93% Total 6/538 (1.12%) Mean 1.22% SD 1.72% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 1/50 (2%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 1/99 (1%) 1/50 (2%) | | Papilloma Squamous 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 30 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 1/50 (2%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.45% SD 0.89% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/542 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/43 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/542 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/542 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/43 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/542 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 31 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.11% SD 0.33% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 1/100(1%) 0/50 (0%) | | Overall Incidence Total 2/549 (0.36%) Mean 0.33% SD 0.71% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) 2/99 (2%) 0/50 (0%) | | 3/50 (6%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/100(1%) 1/50 (2%) | | Overall Incidence Total 8/549 (1.46%) Mean 1.45% SD 1.94% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/50 (0%) 2/99 (2%) 0/50 (0%) | | 3/50 (6%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/100(1%) 1/50 (2%) | | Overall Incidence Total 8/549 (1.46%) Mean 1.45% SD 1.94% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 32 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE COLUMBUS Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 0/549 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/100(0%) 0/50 (0%) 1/50 (2%) 0/99 (0%) 0/50 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/100(0%) 0/50 (0%) 0/50 (0%) 0/100(0%) 0/50 (0%) | | Overall Incidence Total 0/549 (0%) Mean 0% SD 0% Total 1/549 (0.18%) Mean 0.22% SD 0.67% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 33 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 32/50 (64%) 29/50 (58%) 30/50 (60%) 28/49 (57%) 25/50 (50%) 25/50 (50%) | | 32/50 (64%) 31/50 (62%) 27/50 (54%) 19/50 (38%) | | Overall Incidence Total 154/250 (61.6%) Mean 61.6% SD 2.61% Total 124/249 (49.8%) Mean 49.83% SD 7.26% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 23/50 (46%) 21/50 (42%) 22/50 (44%) 22/49 (45%) 20/50 (40%) 23/50 (46%) | | 23/50 (46%) 27/50 (54%) 19/50 (38%) 17/50 (34%) | | Overall Incidence Total 116/250 (46.4%) Mean 46.4% SD 4.56% Total 101/249 (40.56%) Mean 40.58% SD 4.96% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 43/50 (86%) 41/50 (82%) 41/50 (82%) 39/49 (80%) 35/50 (70%) 37/50 (74%) | | 42/50 (84%) 42/50 (84%) 39/50 (78%) 32/50 (64%) | | Overall Incidence Total 209/250 (83.6%) Mean 83.6% SD 1.67% Total 182/249 (73.09%) Mean 73.12% SD 6.31% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 1/50 (2%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.1% Total 3/249 (1.2%) Mean 1.21% SD 1.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 1/50 (2%) 3/50 (6%) 3/50 (6%) 1/49 (2%) 3/50 (6%) 1/50 (2%) | | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 9/250 (3.6%) Mean 3.6% SD 2.19% Total 8/249 (3.21%) Mean 3.21% SD 1.78% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 1/50 (2%) 3/50 (6%) 4/50 (8%) 2/49 (4%) 4/50 (8%) 1/50 (2%) | | 2/50 (4%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 11/250 (4.4%) Mean 4.4% SD 2.61% Total 11/249 (4.42%) Mean 4.42% SD 2.19% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 7/249 (2.81%) Mean 2.8% SD 2.28% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 3/50 (6%) 1/50 (2%) 3/50 (6%) 11/49 (22%) 8/50 (16%) 13/50 (26%) | | Lymphocytic, Mixed, NOS, or 3/50 (6%) 2/50 (4%) 5/50 (10%) 7/50 (14%) | | Undifferentiated Cell Type | | Overall Incidence Total 12/250 (4.8%) Mean 4.8% SD 1.79% Total 44/249 (17.67%) Mean 17.69% SD 6.47% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 34 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 2/49 (4%) 2/50 (4%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 4/49 (8%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 10/246 (4.07%) Mean 4.07% SD 2.5% Total 2/248 (0.81%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/49 (2%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 1/248 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 0/50 (0%) 0/47 (0%) 2/48 (4%) 2/49 (4%) 0/47 (0%) | | 0/48 (0%) 0/50 (0%) 1/49 (2%) 2/49 (4%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 7/242 (2.89%) Mean 2.87% SD 1.84% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/47 (0%) | | 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 1/242 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 0/50 (0%) 0/47 (0%) 2/48 (4%) 2/49 (4%) 0/47 (0%) | | Complex, Malignant, NOS 0/48 (0%) 0/50 (0%) 2/49 (4%) 2/49 (4%) | | Overall Incidence Total 0/244 (0%) Mean 0% SD 0% Total 8/242 (3.31%) Mean 3.28% SD 1.84% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 1/49 (2%) 1/49 (2%) 0/49 (0%) 0/49 (0%) 1/50 (2%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 2/246 (0.81%) Mean 0.82% SD 1.12% Total 2/247 (0.81%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 35 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Benign 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 36 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Coagulating Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor, Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 37 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Sarcoma 0/42 (0%) 0/43 (0%) 0/38 (0%) 0/41 (0%) 0/46 (0%) 0/40 (0%) | | 0/39 (0%) 0/42 (0%) 0/40 (0%) 0/46 (0%) | | Overall Incidence Total 0/204 (0%) Mean 0% SD 0% Total 0/213 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 6/50 (12%) 1/50 (2%) 6/50 (12%) 3/49 (6%) 3/50 (6%) 3/50 (6%) | | 7/50 (14%) 8/50 (16%) 4/50 (8%) 2/50 (4%) | | Overall Incidence Total 28/250 (11.2%) Mean 11.2% SD 5.4% Total 15/249 (6.02%) Mean 6.02% SD 1.42% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 2.61% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 9/50 (18%) 1/50 (2%) 7/50 (14%) 4/49 (8%) 3/50 (6%) 3/50 (6%) | | 7/50 (14%) 8/50 (16%) 5/50 (10%) 2/50 (4%) | | Overall Incidence Total 32/250 (12.8%) Mean 12.8% SD 6.26% Total 17/249 (6.83%) Mean 6.83% SD 2.3% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 38 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Polyp Adenomatous 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 39 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/250 (0.8%) Mean 0.8% SD 1.79% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 1.67% Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/49 (2%) 3/50 (6%) 2/48 (4%) 1/49 (2%) 0/50 (0%) 1/49 (2%) | | 0/48 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 7/245 (2.86%) Mean 2.84% SD 2.3% Total 3/247 (1.21%) Mean 1.22% SD 1.12% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/245 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 40 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 1/49 (2%) 3/50 (6%) 2/48 (4%) 1/49 (2%) 0/50 (0%) 1/49 (2%) | | 0/48 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 7/245 (2.86%) Mean 2.84% SD 2.3% Total 3/247 (1.21%) Mean 1.22% SD 1.12% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 0/49 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/249 (0.8%) Mean 0.8% SD 1.79% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 6/250 (2.4%) Mean 2.4% SD 1.67% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 22/50 (44%) 17/50 (34%) 18/50 (36%) 7/49 (14%) 12/50 (24%) 14/49 (29%) | | 23/50 (46%) 15/50 (30%) 9/50 (18%) 6/50 (12%) | | Overall Incidence Total 95/250 (38%) Mean 38% SD 6.78% Total 48/248 (19.35%) Mean 19.37% SD 6.86% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 10/50 (20%) 11/50 (22%) 9/50 (18%) 4/49 (8%) 6/50 (12%) 4/49 (8%) | | 16/50 (32%) 14/50 (28%) 6/50 (12%) 6/50 (12%) | | Overall Incidence Total 60/250 (24%) Mean 24% SD 5.83% Total 26/248 (10.48%) Mean 10.47% SD 2.1% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 41 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/50 (20%) 11/50 (22%) 9/50 (18%) 4/49 (8%) 6/50 (12%) 4/49 (8%) | | Hepatoblastoma 16/50 (32%) 14/50 (28%) 6/50 (12%) 6/50 (12%) | | Overall Incidence Total 60/250 (24%) Mean 24% SD 5.83% Total 26/248 (10.48%) Mean 10.47% SD 2.1% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 28/50 (56%) 26/50 (52%) 25/50 (50%) 11/49 (22%) 18/50 (36%) 18/49 (37%) | | Hepatocellular Adenoma 34/50 (68%) 26/50 (52%) 13/50 (26%) 12/50 (24%) | | Overall Incidence Total 139/250 (55.6%) Mean 55.6% SD 7.27% Total 72/248 (29.03%) Mean 29.04% SD 6.81% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 28/50 (56%) 26/50 (52%) 25/50 (50%) 11/49 (22%) 18/50 (36%) 18/49 (37%) | | Hepatocellular Adenoma, or 34/50 (68%) 26/50 (52%) 13/50 (26%) 12/50 (24%) | | Hepatoblastoma | | Overall Incidence Total 139/250 (55.6%) Mean 55.6% SD 7.27% Total 72/248 (29.03%) Mean 29.04% SD 6.81% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 8/50 (16%) 13/50 (26%) 13/50 (26%) 1/49 (2%) 3/50 (6%) 2/50 (4%) | | 6/50 (12%) 13/50 (26%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 53/250 (21.2%) Mean 21.2% SD 6.72% Total 9/249 (3.61%) Mean 3.61% SD 1.66% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 8/50 (16%) 6/50 (12%) 6/50 (12%) 6/49 (12%) 1/50 (2%) 1/50 (2%) | | 7/50 (14%) 12/50 (24%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 39/250 (15.6%) Mean 15.6% SD 4.98% Total 8/249 (3.21%) Mean 3.25% SD 5.13% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 15/50 (30%) 18/50 (36%) 17/50 (34%) 7/49 (14%) 4/50 (8%) 3/50 (6%) | | Alveolar/Bronchiolar Adenoma 13/50 (26%) 22/50 (44%) 2/50 (4%) 1/50 (2%) | | Overall Incidence Total 85/250 (34%) Mean 34% SD 6.78% Total 17/249 (6.83%) Mean 6.86% SD 4.72% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 42 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Bronchial: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 43 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% Total 1/248 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 44 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 2/249 (0.8%) Mean 0.81% SD 1.11% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/49 (2%) 0/47 (0%) 2/50 (4%) | | 1/49 (2%) 1/48 (2%) | | Overall Incidence Total 5/243 (2.06%) Mean 2.03% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 1/49 (2%) 0/47 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 1/49 (2%) 0/47 (0%) 0/50 (0%) | | Malignant, NOS 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 1/49 (2%) 0/47 (0%) 0/50 (0%) | | 1/49 (2%) 0/48 (0%) | | Overall Incidence Total 2/243 (0.82%) Mean 0.82% SD 1.12% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) 0/47 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/49 (2%) 0/47 (0%) 2/50 (4%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 3/243 (1.23%) Mean 1.21% SD 1.79% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 45 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) 0/47 (0%) 0/50 (0%) | | 1/49 (2%) 0/48 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) 0/47 (0%) 0/50 (0%) | | 0/49 (0%) 0/48 (0%) | | Overall Incidence Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/48 (2%) 0/48 (0%) 0/43 (0%) 13/49 (27%) 10/50 (20%) 9/48 (19%) | | Adenoma 0/49 (0%) 1/50 (2%) 10/47 (21%) 8/49 (16%) | | Overall Incidence Total 2/238 (0.84%) Mean 0.82% SD 1.12% Total 50/243 (20.58%) Mean 20.58% SD 3.8% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/48 (0%) 0/43 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | | Carcinoma 0/49 (0%) 1/50 (2%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 1/238 (0.42%) Mean 0.4% SD 0.89% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 1/48 (2%) 0/48 (0%) 0/43 (0%) 13/49 (27%) 10/50 (20%) 9/48 (19%) | | Carcinoma or Adenoma 0/49 (0%) 2/50 (4%) 10/47 (21%) 8/49 (16%) | | Overall Incidence Total 3/238 (1.26%) Mean 1.22% SD 1.8% Total 50/243 (20.58%) Mean 20.58% SD 3.8% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/48 (0%) 0/43 (0%) 1/49 (2%) 0/50 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/48 (0%) 0/43 (0%) 1/49 (2%) 0/50 (0%) 0/48 (0%) | | 0/49 (0%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | | Overall Incidence Total 0/238 (0%) Mean 0% SD 0% Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/48 (0%) 0/50 (0%) 1/49 (2%) | | 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 46 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/48 (0%) 0/50 (0%) 1/49 (2%) | | 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 1/243 (0.41%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/48 (0%) 0/50 (0%) 0/49 (0%) | | 0/46 (0%) 0/50 (0%) | | Overall Incidence Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 47 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma, Basosq. Tumor (M or 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 48 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 3/249 (1.2%) Mean 1.2% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 49 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, Squamous Cell 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Papilloma, or Keratoacanthoma 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | | Myxoma, Myxosarcoma, or Fibrous 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 6/249 (2.41%) Mean 2.42% SD 1.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | | Myxosarcoma, or Fibrous 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Histiocytoma | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 6/249 (2.41%) Mean 2.42% SD 1.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 50 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 6/249 (2.41%) Mean 2.42% SD 1.69% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 0/49 (0%) 2/50 (4%) 2/48 (4%) 1/49 (2%) 1/50 (2%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) | | Overall Incidence Total 4/246 (1.63%) Mean 1.63% SD 2.24% Total 5/247 (2.02%) Mean 2.02% SD 1.41% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 4/250 (1.6%) Mean 1.6% SD 2.19% Total 3/249 (1.2%) Mean 1.2% SD 1.79% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 51 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 3/250 (1.2%) Mean 1.2% SD 1.79% Total 2/249 (0.8%) Mean 0.8% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 0/50 (0%) 2/50 (4%) 2/50 (4%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 5/250 (2%) Mean 2% SD 2% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Seratoli Tumor: Benign, 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Sertoli Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/44 (0%) 0/35 (0%) 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/45 (0%) | | 0/41 (0%) 0/35 (0%) 0/43 (0%) 0/44 (0%) | | Overall Incidence Total 0/195 (0%) Mean 0% SD 0% Total 0/227 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/44 (0%) 0/35 (0%) 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/45 (0%) | | 0/41 (0%) 0/35 (0%) 0/43 (0%) 0/44 (0%) | | Overall Incidence Total 0/195 (0%) Mean 0% SD 0% Total 0/227 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 52 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/44 (0%) 0/35 (0%) 0/40 (0%) 0/48 (0%) 0/47 (0%) 0/45 (0%) | | 0/41 (0%) 0/35 (0%) 0/43 (0%) 0/44 (0%) | | Overall Incidence Total 0/195 (0%) Mean 0% SD 0% Total 0/227 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/240 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/240 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/240 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/48 (0%) 0/47 (0%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 1/49 (2%) 0/48 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 2/240 (0.83%) Mean 0.82% SD 1.13% Total 3/248 (1.21%) Mean 1.21% SD 1.79% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/48 (0%) 1/47 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/240 (0.42%) Mean 0.43% SD 0.95% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/48 (0%) 1/47 (2%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | 1/49 (2%) 0/48 (0%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 3/240 (1.25%) Mean 1.25% SD 1.14% Total 3/248 (1.21%) Mean 1.21% SD 1.79% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 53 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | | Papilloma Squamous 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/250 (0.4%) Mean 0.4% SD 0.89% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/49 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 2/246 (0.81%) Mean 0.82% SD 1.12% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/49 (0%) 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 1/50 (2%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 2/246 (0.81%) Mean 0.82% SD 1.12% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) | | Overall Incidence Total 0/246 (0%) Mean 0% SD 0% Total 0/243 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 1/49 (2%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 54 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/49 (0%) 1/50 (2%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/249 (0.4%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 4/249 (1.61%) Mean 1.6% SD 2.19% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/249 (0.8%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/49 (0%) 0/50 (0%) 1/50 (2%) | | 3/50 (6%) 2/50 (4%) | | Overall Incidence Total 6/249 (2.41%) Mean 2.4% SD 2.61% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 55 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: BATTELLE NORTHWEST Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/250 (0%) Mean 0% SD 0% Total 0/249 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied This page intentionally left blank Toxicology Data Management System Page: 57 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 54/100(54%) 52/100(52%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 40/100(40%) 55/100(55%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 71/100(71%) 78/100(78%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 6/100(6%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 6/100(6%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 1/100(1%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 8/100(8%) 32/100(32%) | | Lymphocytic, Mixed, NOS, or | | Undifferentiated Cell Type | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/100(0%) 0/100(0%) | | NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 58 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 3/99 (3%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/99 (0%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Sarcoma 0/99 (0%) 1/92 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 1/98 (1%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 2/98 (2%) 0/90 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 2/98 (2%) 0/90 (0%) | | Complex, Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/99 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Benign 1/99 (1%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/99 (0%) 0/96 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 59 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/100(0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/100(0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/100(0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/100(0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/100(0%) 0/99 (0%) | | Astrocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/100(0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 60 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Coagulating Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor, Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangiosarcoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Sarcoma 0/84 (0%) 0/70 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 12/100(12%) 10/100(10%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 0/100(0%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 12/100(12%) 12/100(12%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/100(0%) 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/100(0%) 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 61 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Polyp Adenomatous 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 62 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/100(1%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 1/99 (1%) 2/87 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 2/99 (2%) 0/87 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 3/99 (3%) 2/87 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/99 (1%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 1/99 (1%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 2/99 (2%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/99 (0%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/100(0%) 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 4/100(4%) 1/98 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 63 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 2/100(2%) 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 30/100(30%) 17/98 (17%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 19/100(19%) 6/98 (6%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 21/100(21%) 6/98 (6%) | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 46/100(46%) 22/98 (22%) | | Hepatocellular Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 47/100(47%) 22/98 (22%) | | Hepatocellular Adenoma, or | | Hepatoblastoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/100(0%) 1/98 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/100(0%) 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/100(0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 26/100(26%) 9/95 (9%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 8/100(8%) 2/95 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 30/100(30%) 11/95 (12%) | | Alveolar/Bronchiolar Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 64 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/100(0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/100(0%) 0/95 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Bronchial: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Mast Cell Tumor Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 65 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/100(0%) 1/100(1%) | | or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/99 (0%) 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/100(0%) 0/100(0%) | | Papilloma Squamous, or Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 66 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 3/79 (4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 2/79 (3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 2/79 (3%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 1/79 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/79 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/99 (0%) 0/87 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/99 (0%) 0/87 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/83 (0%) 17/83 (20%) | | Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/83 (0%) 0/83 (0%) | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 67 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/83 (0%) 17/83 (20%) | | Carcinoma or Adenoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/83 (0%) 1/83 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/83 (0%) 1/83 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/98 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/99 (0%) 1/94 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/99 (0%) 1/94 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/100(0%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/100(0%) 3/100(3%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 68 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/100(0%) 0/100(0%) | | Basosquamous Tumor Benign | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/100(0%) 0/100(0%) | | Tumor Benign, or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/100(0%) 1/100(1%) | | Basosquamous Tumor (malignant or | | NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/100(0%) 1/100(1%) | | Adenoma, Basosquamous Tumor | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 0/100(0%) 1/100(1%) | | Carcinoma, Basosq. Tumor (M or | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 69 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/100(0%) 1/100(1%) | | Cell Carcinoma, Basosquamous | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 0/100(0%) 0/100(0%) | | Papilloma | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 70 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/100(0%) 0/100(0%) | | Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 0/100(0%) 0/100(0%) | | Papilloma, or Keratoacanthoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/100(0%) 4/100(4%) | | Myxoma, Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/100(0%) 4/100(4%) | | Myxosarcoma, or Fibrous | | Histiocytoma | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/100(0%) 2/100(2%) | | (malignant or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/100(0%) 2/100(2%) | | or Schwannoma (benign, malignant | | or NOS) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/100(0%) 4/100(4%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/100(0%) 2/100(2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 71 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/99 (0%) 0/91 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 2/99 (2%) 0/91 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/99 (0%) 0/91 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/99 (0%) 1/91 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 0/100(0%) 1/100(1%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/99 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangiosarcoma 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 72 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Testes: | | Seratoli Tumor: Benign, 0/99 (0%) | | Malignant, NOS | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Testes: | | Sertoli Cell Tumor Malignant 0/99 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/69 (0%) 0/78 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/69 (0%) 1/78 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/69 (0%) 1/78 (1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 1/99 (1%) 2/92 (2%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/99 (0%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/99 (0%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 0/99 (0%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/99 (0%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 0/99 (0%) 0/92 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/100(0%) 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 73 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/100(0%) 0/100(0%) | | Papilloma Squamous | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Tooth: | | Sarcoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/98 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/98 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/98 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/98 (0%) 0/79 (0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 74 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: IITRI Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 1/100(1%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 0/100(0%) 0/100(0%) | | Overall Incidence | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 75 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Benign Tumors 37/50 (74%) 23/50 (46%) 30/60 (50%) 27/50 (54%) 13/50 (26%) 21/60 (35%) | | 25/50 (50%) 32/50 (64%) 17/50 (34%) 15/50 (30%) | | Overall Incidence Total 147/260 (56.54%)Mean 56.8% SD 11.8% Total 93/260 (35.77%) Mean 35.8% SD 10.78% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Tumors 23/50 (46%) 20/50 (40%) 26/60 (43%) 17/50 (34%) 12/50 (24%) 16/60 (27%) | | 14/50 (28%) 29/50 (58%) 9/50 (18%) 21/50 (42%) | | Overall Incidence Total 112/260 (43.08%)Mean 43.07% SD 10.82% Total 75/260 (28.85%) Mean 28.93% SD 9.29% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant and Benign Tumors 45/50 (90%) 32/50 (64%) 45/60 (75%) 39/50 (78%) 23/50 (46%) 33/60 (55%) | | 31/50 (62%) 44/50 (88%) 21/50 (42%) 31/50 (62%) | | Overall Incidence Total 197/260 (75.77%)Mean 75.8% SD 13.05% Total 147/260 (56.54%) Mean 56.6% SD 14.28% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangioma 1/50 (2%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 3/60 (5%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/260 (0.77%) Mean 0.73% SD 1.01% Total 4/260 (1.54%) Mean 1.4% SD 2.19% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma 4/50 (8%) 2/50 (4%) 4/60 (7%) 1/50 (2%) 2/50 (4%) 0/60 (0%) | | 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 14/260 (5.38%) Mean 5.33% SD 2.36% Total 4/260 (1.54%) Mean 1.6% SD 1.67% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Hemangiosarcoma or Hemangioma 5/50 (10%) 2/50 (4%) 5/60 (8%) 1/50 (2%) 2/50 (4%) 3/60 (5%) | | 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | | Overall Incidence Total 16/260 (6.15%) Mean 6.07% SD 3.22% Total 8/260 (3.08%) Mean 3% SD 2% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Histiocytic Sarcoma 0/50 (0%) 1/50 (2%) 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 3/260 (1.15%) Mean 1.13% SD 1.04% Total 2/260 (0.77%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Malignant Lymphoma: Histiocytic, 2/50 (4%) 2/50 (4%) 3/60 (5%) 4/50 (8%) 6/50 (12%) 8/60 (13%) | | Lymphocytic, Mixed, NOS, or 3/50 (6%) 3/50 (6%) 3/50 (6%) 7/50 (14%) | | Undifferentiated Cell Type | | Overall Incidence Total 13/260 (5%) Mean 5% SD 1% Total 28/260 (10.77%) Mean 10.67% SD 3.5% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Benign, Malignant, 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | NOS 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Mesothelioma: Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 76 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#All Organs: | | Osteosarcoma or Osteoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 2/260 (0.77%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Adenoma 4/50 (8%) 0/50 (0%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 1/59 (2%) | | 3/49 (6%) 3/49 (6%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 12/258 (4.65%) Mean 4.72% SD 3.12% Total 1/259 (0.39%) Mean 0.34% SD 0.76% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/259 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Cortex: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/259 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Benign 0/49 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/59 (0%) | | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/257 (0%) Mean 0% SD 0% Total 1/258 (0.39%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma Malignant 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/49 (0%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/257 (0.39%) Mean 0.41% SD 0.91% Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Adrenal Medulla: | | Pheochromocytoma: Benign, 0/49 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/59 (0%) | | Complex, Malignant, NOS 0/49 (0%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 1/257 (0.39%) Mean 0.41% SD 0.91% Total 1/258 (0.39%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/260 (0.77%) Mean 0.8% SD 1.1% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 77 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Bone Marrow: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.33% SD 0.75% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondroma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Chondrosarcoma or Chondroma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Bone: | | Osteosarcoma or Osteoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 2/260 (0.77%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Meningioma: Benign, Malignant, NOS 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 78 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Benign 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Oligodendroglioma, Glioma, or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Astrocytoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Brain: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Clitoral/Preputial Gland: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Coagulating Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Ear: | | Neural Crest Tumor, Malignant 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.33% SD 0.75% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 79 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Epididymis: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Eye: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Gallbladder: | | Sarcoma 0/48 (0%) 0/46 (0%) 0/54 (0%) 0/44 (0%) 0/49 (0%) 0/54 (0%) | | 0/49 (0%) 0/44 (0%) 0/49 (0%) 1/45 (2%) | | Overall Incidence Total 0/241 (0%) Mean 0% SD 0% Total 1/241 (0.41%) Mean 0.44% SD 0.99% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Adenoma 7/50 (14%) 9/50 (18%) 4/60 (7%) 7/50 (14%) 3/50 (6%) 4/60 (7%) | | 3/50 (6%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | | Overall Incidence Total 27/260 (10.38%) Mean 10.53% SD 5.24% Total 18/260 (6.92%) Mean 6.93% SD 4.13% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma 2/50 (4%) 1/50 (2%) 1/60 (2%) 0/50 (0%) 1/50 (2%) 1/60 (2%) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | | Overall Incidence Total 6/260 (2.31%) Mean 2.33% SD 1.7% Total 4/260 (1.54%) Mean 1.53% SD 1.66% | __________________________________________________________________________________________________________________________________ |#Harderian Gland: | | Carcinoma or Adenoma 9/50 (18%) 10/50 (20%) 5/60 (8%) 7/50 (14%) 4/50 (8%) 5/60 (8%) | | 3/50 (6%) 6/50 (12%) 2/50 (4%) 4/50 (8%) | | Overall Incidence Total 33/260 (12.69%) Mean 12.87% SD 6.04% Total 22/260 (8.46%) Mean 8.47% SD 3.57% | __________________________________________________________________________________________________________________________________ |*Heart: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/259 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Heart: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/259 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 80 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Cecum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Large: Colon/Rectum | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.33% SD 0.75% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Duodenum | | Polyp Adenomatous 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Ileum | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 81 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Carcinoma 1/50 (2%) 1/50 (2%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/260 (1.54%) Mean 1.47% SD 1.45% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Jejunum | | Polyp Adenomatous 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma 1/50 (2%) 1/50 (2%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/260 (1.54%) Mean 1.47% SD 1.45% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/260 (1.54%) Mean 1.47% SD 1.45% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.33% SD 0.75% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Intestine Small: Site Unspecified | | Polyp Adenomatous 0/50 (0%) 1/50 (2%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Adenoma 2/50 (4%) 0/50 (0%) 0/59 (0%) 1/47 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 3/49 (6%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 5/258 (1.94%) Mean 2.02% SD 2.87% Total 1/255 (0.39%) Mean 0.43% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/47 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 82 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Islets, Pancreatic: | | Carcinoma or Adenoma 2/50 (4%) 0/50 (0%) 0/59 (0%) 1/47 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 3/49 (6%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 5/258 (1.94%) Mean 2.02% SD 2.87% Total 1/255 (0.39%) Mean 0.43% SD 0.95% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Adenoma 1/50 (2%) 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 2/257 (0.78%) Mean 0.81% SD 1.11% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma 0/50 (0%) 1/50 (2%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/257 (0.39%) Mean 0.4% SD 0.89% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Carcinoma or Adenoma 1/50 (2%) 1/50 (2%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 3/257 (1.17%) Mean 1.21% SD 1.1% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Kidney: Renal Tubule | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/58 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/257 (0%) Mean 0% SD 0% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 6/260 (2.31%) Mean 2.33% SD 0.94% Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatoblastoma 2/50 (4%) 0/50 (0%) 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 3/50 (6%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 6/260 (2.31%) Mean 2.33% SD 2.62% Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Adenoma 23/50 (46%) 7/50 (14%) 18/60 (30%) 11/50 (22%) 3/50 (6%) 7/60 (12%) | | 14/50 (28%) 16/50 (32%) 6/49 (12%) 9/49 (18%) | | Overall Incidence Total 78/260 (30%) Mean 30% SD 11.4% Total 36/258 (13.95%) Mean 14.06% SD 6.24% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma 8/50 (16%) 4/50 (8%) 12/60 (20%) 3/50 (6%) 2/50 (4%) 2/60 (3%) | | 8/50 (16%) 23/50 (46%) 3/49 (6%) 8/49 (16%) | | Overall Incidence Total 55/260 (21.15%) Mean 21.2% SD 14.53% Total 18/258 (6.98%) Mean 7.16% SD 5.27% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 83 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 10/50 (20%) 4/50 (8%) 13/60 (22%) 3/50 (6%) 2/50 (4%) 2/60 (3%) | | Hepatoblastoma 8/50 (16%) 24/50 (48%) 3/49 (6%) 8/49 (16%) | | Overall Incidence Total 59/260 (22.69%) Mean 22.73% SD 15.08% Total 18/258 (6.98%) Mean 7.16% SD 5.27% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma or 31/50 (62%) 10/50 (20%) 27/60 (45%) 13/50 (26%) 4/50 (8%) 9/60 (15%) | | Hepatocellular Adenoma 20/50 (40%) 36/50 (72%) 8/49 (16%) 16/49 (33%) | | Overall Incidence Total 124/260 (47.69%)Mean 47.8% SD 20.18% Total 50/258 (19.38%) Mean 19.6% SD 9.72% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocellular Carcinoma, 31/50 (62%) 10/50 (20%) 28/60 (47%) 13/50 (26%) 4/50 (8%) 9/60 (15%) | | Hepatocellular Adenoma, or 20/50 (40%) 36/50 (72%) 8/49 (16%) 16/49 (33%) | | Hepatoblastoma | | Overall Incidence Total 125/260 (48.08%)Mean 48.13% SD 20.14% Total 50/258 (19.38%) Mean 19.6% SD 9.72% | __________________________________________________________________________________________________________________________________ |*Liver: | | Hepatocholangiocarcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 2/260 (0.77%) Mean 0.8% SD 1.79% Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Liver: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/258 (0.39%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Lung: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/259 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Adenoma 11/50 (22%) 11/50 (22%) 9/60 (15%) 2/49 (4%) 4/50 (8%) 2/60 (3%) | | 6/50 (12%) 12/50 (24%) 5/50 (10%) 1/50 (2%) | | Overall Incidence Total 49/260 (18.85%) Mean 19% SD 5.2% Total 14/259 (5.41%) Mean 5.48% SD 3.37% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma 9/50 (18%) 6/50 (12%) 5/60 (8%) 0/49 (0%) 0/50 (0%) 3/60 (5%) | | 2/50 (4%) 7/50 (14%) 1/50 (2%) 1/50 (2%) | | Overall Incidence Total 29/260 (11.15%) Mean 11.27% SD 5.36% Total 5/259 (1.93%) Mean 1.8% SD 2.05% | __________________________________________________________________________________________________________________________________ |*Lung: | | Alveolar/Bronchiolar Carcinoma or 19/50 (38%) 14/50 (28%) 14/60 (23%) 2/49 (4%) 4/50 (8%) 5/60 (8%) | | Alveolar/Bronchiolar Adenoma 8/50 (16%) 18/50 (36%) 6/50 (12%) 2/50 (4%) | | Overall Incidence Total 73/260 (28.08%) Mean 28.27% SD 9.07% Total 19/259 (7.34%) Mean 7.28% SD 3.35% | __________________________________________________________________________________________________________________________________ |*Lung: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/259 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 84 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Lung: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/49 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/259 (0.39%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Bronchial: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mandibular: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mediastinal: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Fibrous Histiocytoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Plasma Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Lymph Node, Mesenteric: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 2/260 (0.77%) Mean 0.73% SD 1.01% | __________________________________________________________________________________________________________________________________ |#Lymph Node: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 85 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 2/260 (0.77%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 2/260 (0.77%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mammary Gland: | | Fibroma, Fibroadenoma, Carcinoma, 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 1/50 (2%) 0/60 (0%) | | or Adenoma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 2/260 (0.77%) Mean 0.8% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Fibrosarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Mesentery: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Nose: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Papilloma Squamous or Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 86 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Cavity (Oral Mucosa, Tongue, | | Pharynx, Tooth, Gingiva): | | Squamous Cell Carcinoma, 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous, or Papilloma 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Oral Mucosa: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Cystadenoma 1/49 (2%) 0/50 (0%) 1/59 (2%) | | 3/48 (6%) 1/49 (2%) | | Overall Incidence Total 6/255 (2.35%) Mean 2.41% SD 2.31% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor Benign 0/49 (0%) 0/50 (0%) 0/59 (0%) | | 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 1/255 (0.39%) Mean 0.42% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Granulosa Cell Tumor: Benign, 0/49 (0%) 0/50 (0%) 0/59 (0%) | | Malignant, NOS 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 1/255 (0.39%) Mean 0.42% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangioma 0/49 (0%) 0/50 (0%) 0/59 (0%) | | 1/48 (2%) 0/49 (0%) | | Overall Incidence Total 1/255 (0.39%) Mean 0.42% SD 0.93% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Hemangiosarcoma 0/49 (0%) 0/50 (0%) 0/59 (0%) | | 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Luteoma 1/49 (2%) 0/50 (0%) 2/59 (3%) | | 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 3/255 (1.18%) Mean 1.09% SD 1.56% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 87 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Ovary: | | Teratoma Benign 0/49 (0%) 0/50 (0%) 0/59 (0%) | | 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Ovary: | | Thecoma Benign 0/49 (0%) 0/50 (0%) 0/59 (0%) | | 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/47 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pancreas: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/47 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 1/255 (0.39%) Mean 0.41% SD 0.91% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) 1/53 (2%) 2/46 (4%) 1/50 (2%) 3/58 (5%) | | Adenoma 0/46 (0%) 1/49 (2%) 0/45 (0%) 5/48 (10%) | | Overall Incidence Total 2/245 (0.82%) Mean 0.79% SD 1.08% Total 11/247 (4.45%) Mean 4.39% SD 3.93% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) 0/53 (0%) 0/46 (0%) 0/50 (0%) 0/58 (0%) | | Carcinoma 0/46 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/245 (0%) Mean 0% SD 0% Total 0/247 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Distalis or | | Unspecified Site 0/48 (0%) 0/49 (0%) 1/53 (2%) 2/46 (4%) 1/50 (2%) 3/58 (5%) | | Carcinoma or Adenoma 0/46 (0%) 1/49 (2%) 0/45 (0%) 5/48 (10%) | | Overall Incidence Total 2/245 (0.82%) Mean 0.79% SD 1.08% Total 11/247 (4.45%) Mean 4.39% SD 3.93% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Adenoma 0/48 (0%) 0/49 (0%) 0/53 (0%) 2/46 (4%) 0/50 (0%) 0/58 (0%) | | 0/46 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/245 (0%) Mean 0% SD 0% Total 2/247 (0.81%) Mean 0.87% SD 1.94% | __________________________________________________________________________________________________________________________________ |*Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma 0/48 (0%) 0/49 (0%) 0/53 (0%) 2/46 (4%) 0/50 (0%) 0/58 (0%) | | 0/46 (0%) 0/49 (0%) 0/45 (0%) 0/48 (0%) | | Overall Incidence Total 0/245 (0%) Mean 0% SD 0% Total 2/247 (0.81%) Mean 0.87% SD 1.94% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Adenoma 0/49 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 88 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Prostate: | | Carcinoma or Adenoma 0/49 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Prostate: | | Hemangiosarcoma 0/49 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Salivary Glands: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/258 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Seminal Vesicle: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.33% SD 0.75% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Rhabdomyosarcoma or Rhabdomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skeletal Muscle: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 5/50 (10%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 6/260 (2.31%) Mean 2.4% SD 4.34% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 89 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: Sebaceous Gland | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Basosquamous Tumor Benign 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Adenoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Tumor Benign, or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Trichoepithelioma | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Basosquamous Tumor (malignant or 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | NOS) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal Cell Carcinoma, Basal Cell 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Adenoma, Basosquamous Tumor 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | (benign, malignant or NOS), or | | Trichoepithelioma | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Basal or Sq. Cell Carcinoma, 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Carcinoma, Basosq. Tumor (M or 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | B), Basal Cell Adenoma, Adenoma, | | Papilloma, Sq Papilloma, | | Keratoacanthoma, | | Trichoepithelioma | | Overall Incidence Total 3/260 (1.15%) Mean 1.2% SD 1.79% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 90 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangioma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Hemangiosarcoma 1/50 (2%) 1/50 (2%) 0/60 (0%) 1/50 (2%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 2/260 (0.77%) Mean 0.8% SD 1.1% Total 3/260 (1.15%) Mean 1.2% SD 1.1% | __________________________________________________________________________________________________________________________________ |#Skin: | | Keratoacanthoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Lipoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Mast Cell Tumor Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Melanoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neural Crest Tumor 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Osteosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Carcinoma, Basal 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Cell Carcinoma, Basosquamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Tumor (malignant or NOS), or | | Carcinoma | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 91 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/260 (0.77%) Mean 0.8% SD 1.1% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma or 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/260 (0.77%) Mean 0.8% SD 1.1% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma, Squamous Cell 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Carcinoma or Keratoacanthoma | | Overall Incidence Total 3/260 (1.15%) Mean 1.2% SD 1.79% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Squamous Cell Papilloma, 2/50 (4%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma, or Keratoacanthoma 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 3/260 (1.15%) Mean 1.2% SD 1.79% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibroma, Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Myxoma, Myxosarcoma, or Fibrous 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | Histiocytoma | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 6/260 (2.31%) Mean 2.33% SD 2.62% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Fibrosarcoma, Sarcoma, 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | Myxosarcoma, or Fibrous 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | | Histiocytoma | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 6/260 (2.31%) Mean 2.33% SD 2.62% | __________________________________________________________________________________________________________________________________ |#Skin: | | Myxosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma or Schwannoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | (malignant or NOS) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 92 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Skin: | | Neurofibrosarcoma, Neurofibroma, 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | or Schwannoma (benign, malignant 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | or NOS) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Skin: | | Sarcoma 0/50 (0%) 1/50 (2%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 5/260 (1.92%) Mean 1.93% SD 2.45% | __________________________________________________________________________________________________________________________________ |#Skin: | | Schwannoma Malignant 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangioma 0/49 (0%) 0/50 (0%) 1/60 (2%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 1/258 (0.39%) Mean 0.33% SD 0.75% Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Hemangiosarcoma 2/49 (4%) 1/50 (2%) 2/60 (3%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 6/258 (2.33%) Mean 2.29% SD 1.56% Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Mast Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Spleen: | | Plasma Cell Tumor Malignant 0/49 (0%) 0/50 (0%) 0/60 (0%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/255 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.33% SD 0.75% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Carcinoma or 2/50 (4%) 0/50 (0%) 0/60 (0%) 2/50 (4%) 2/50 (4%) 1/60 (2%) | | Papilloma Squamous 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/260 (1.54%) Mean 1.6% SD 1.67% Total 5/260 (1.92%) Mean 1.93% SD 2.01% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 93 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Stomach, Forestomach: | | Squamous Cell Papilloma 2/50 (4%) 0/50 (0%) 0/60 (0%) 2/50 (4%) 2/50 (4%) 1/60 (2%) | | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 4/260 (1.54%) Mean 1.6% SD 1.67% Total 5/260 (1.92%) Mean 1.93% SD 2.01% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Stomach, Glandular: | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Adenoma 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangioma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Testes: | | Seratoli Tumor: Benign, 0/50 (0%) 1/50 (2%) 0/60 (0%) | | Malignant, NOS 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Testes: | | Sertoli Cell Tumor Malignant 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Hemangioma 0/44 (0%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 0/50 (0%) 0/57 (0%) | | 0/47 (0%) 0/42 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/237 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma Benign 0/44 (0%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 0/50 (0%) 0/57 (0%) | | 0/47 (0%) 0/42 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/237 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 94 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |*Thymus: | | Thymoma: Benign, Malignant, NOS 0/44 (0%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 0/50 (0%) 0/57 (0%) | | 0/47 (0%) 0/42 (0%) 0/48 (0%) 0/49 (0%) | | Overall Incidence Total 0/237 (0%) Mean 0% SD 0% Total 0/248 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: | | Adenoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: C-Cell | | Carcinoma or Adenoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Adenoma 1/50 (2%) 0/50 (0%) 1/59 (2%) 1/49 (2%) 1/49 (2%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/258 (0.78%) Mean 0.74% SD 1.02% Total 2/257 (0.78%) Mean 0.82% SD 1.12% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/49 (0%) 0/49 (0%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 0/258 (0%) Mean 0% SD 0% Total 0/257 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 1/59 (2%) 1/49 (2%) 1/49 (2%) 0/60 (0%) | | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | | Overall Incidence Total 2/258 (0.78%) Mean 0.74% SD 1.02% Total 2/257 (0.78%) Mean 0.82% SD 1.12% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Rhabdomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tissue NOS: | | Sarcoma 0/50 (0%) 0/50 (0%) 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 2/260 (0.77%) Mean 0.67% SD 1.49% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 95 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Carcinoma or 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | Papilloma Squamous 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tongue: | | Squamous Cell Papilloma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Odontoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Tooth: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Carcinoma or Papilloma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/259 (0%) Mean 0% SD 0% Total 0/256 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Hemangiosarcoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/259 (0%) Mean 0% SD 0% Total 0/256 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Papilloma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | Overall Incidence Total 0/259 (0%) Mean 0% SD 0% Total 0/256 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |*Urinary Bladder: | | Sarcoma 0/50 (0%) 0/50 (0%) 0/59 (0%) 0/48 (0%) 0/50 (0%) 0/59 (0%) | | 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | | Overall Incidence Total 0/259 (0%) Mean 0% SD 0% Total 1/256 (0.39%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Adenoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 1/50 (2%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 96 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangioma 0/50 (0%) 0/50 (0%) 1/60 (2%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.33% SD 0.75% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Hemangiosarcoma 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Leiomyosarcoma 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Polyp Stromal 0/50 (0%) 0/50 (0%) 2/60 (3%) | | 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 5/260 (1.92%) Mean 1.87% SD 2.72% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma 1/50 (2%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal 0/50 (0%) 1/50 (2%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% | __________________________________________________________________________________________________________________________________ |#Uterus: | | Sarcoma Stromal or Polyp Stromal 0/50 (0%) 1/50 (2%) 2/60 (3%) | | 3/50 (6%) 0/50 (0%) | | Overall Incidence Total 6/260 (2.31%) Mean 2.27% SD 2.52% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Adenoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma 0/50 (0%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 0/260 (0%) Mean 0% SD 0% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________ *: Denominator is number of animals with tissues examined microscopically #: Denominator is number of animals necropsied Toxicology Data Management System Page: 97 Version: 02/27/03 Tumor Incidence for Selected Control Animal Groups Contract/Lab: SOUTHERN RESEARCH Route: ALL ROUTES Date of Species: MICE Vehicle: ALL VEHICLES Input File: 27-FEB-2003 Strain: B6C3F1 Length of Study: CHRONIC Incidence Data for Vehicle Control Groups __________________________________________________________________________________________________________________________________ | Male Female | __________________________________________________________________________________________________________________________________ |#Zymbal's Gland: | | Carcinoma or Adenoma 1/50 (2%) 0/50 (0%) 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | Overall Incidence Total 1/260 (0.38%) Mean 0.4% SD 0.89% Total 0/260 (0%) Mean 0% SD 0% | __________________________________________________________________________________________________________________________________